Medicine Surgery

Peripheral Artery Disease Management

Description

This cluster of papers focuses on the management, treatment, and epidemiology of peripheral arterial disease (PAD), covering topics such as guidelines for diagnosis and treatment, comparison of revascularization methods, risk factors, and the impact of PAD on patients with diabetes. It also includes discussions on the use of ankle-brachial index, stents, and the prevalence of atherosclerosis-related conditions.

Keywords

Peripheral Arterial Disease; Guidelines; Angioplasty; Atherosclerosis; Claudication; Revascularization; Risk Factors; Ankle-Brachial Index; Stents; Diabetes

Background —Among apparently healthy men, elevated levels of C-reactive protein (CRP), a marker for systemic inflammation, predict risk of myocardial infarction and thromboembolic stroke. Whether increased levels of CRP are … Background —Among apparently healthy men, elevated levels of C-reactive protein (CRP), a marker for systemic inflammation, predict risk of myocardial infarction and thromboembolic stroke. Whether increased levels of CRP are also associated with the development of symptomatic peripheral arterial disease (PAD) is unknown. Methods and Results —Using a prospective, nested, case-control design, we measured baseline levels of CRP in 144 apparently healthy men participating in the Physicians’ Health Study who subsequently developed symptomatic PAD (intermittent claudication or need for revascularization) and in an equal number of control subjects matched on the basis of age and smoking habit who remained free of vascular disease during a follow-up period of 60 months. Median CRP levels at baseline were significantly higher among those who subsequently developed PAD (1.34 versus 0.99 mg/L; P =.04). Furthermore, the risks of developing PAD increased significantly with each increasing quartile of baseline CRP concentration such that relative risks of PAD from lowest (referent) to highest quartile of CRP were 1.0, 1.3, 2.0, and 2.1 ( P trend =.02). Compared with those with no clinical evidence of disease, the subgroup of case patients who required revascularization had the highest baseline CRP levels (median=1.75 mg/L; P =.04); relative risks from lowest to highest quartile of CRP for this end point were 1.0, 1.8, 3.8, and 4.1 ( P trend =.02). Risk estimates were similar after additional control for body mass index, hypercholesterolemia, hypertension, diabetes, and a family history of premature atherosclerosis. Conclusions —These prospective data indicate that among apparently healthy men, baseline levels of CRP predict future risk of developing symptomatic PAD and thus provide further support for the hypothesis that chronic inflammation is important in the pathogenesis of atherothrombosis.
<b>Objective</b> To determine whether aspirin and antioxidant therapy, combined or alone, are more effective than placebo in reducing the development of cardiovascular events in patients with diabetes mellitus and asymptomatic … <b>Objective</b> To determine whether aspirin and antioxidant therapy, combined or alone, are more effective than placebo in reducing the development of cardiovascular events in patients with diabetes mellitus and asymptomatic peripheral arterial disease. <b>Design</b> Multicentre, randomised, double blind, 2×2 factorial, placebo controlled trial. <b>Setting</b> 16 hospital centres in Scotland, supported by 188 primary care groups. <b>Participants</b> 1276 adults aged 40 or more with type 1 or type 2 diabetes and an ankle brachial pressure index of 0.99 or less but no symptomatic cardiovascular disease. <b>Interventions</b> Daily, 100 mg aspirin tablet plus antioxidant capsule (n=320), aspirin tablet plus placebo capsule (n=318), placebo tablet plus antioxidant capsule (n=320), or placebo tablet plus placebo capsule (n=318). <b>Main outcome measures</b> Two hierarchical composite primary end points of death from coronary heart disease or stroke, non-fatal myocardial infarction or stroke, or amputation above the ankle for critical limb ischaemia; and death from coronary heart disease or stroke. <b>Results</b> No evidence was found of any interaction between aspirin and antioxidant. Overall, 116 of 638 primary events occurred in the aspirin groups compared with 117 of 638 in the no aspirin groups (18.2% <i>v</i> 18.3%): hazard ratio 0.98 (95% confidence interval 0.76 to 1.26). Forty three deaths from coronary heart disease or stroke occurred in the aspirin groups compared with 35 in the no aspirin groups (6.7% <i>v </i>5.5%): 1.23 (0.79 to 1.93). Among the antioxidant groups 117 of 640 (18.3%) primary events occurred compared with 116 of 636 (18.2%) in the no antioxidant groups (1.03, 0.79 to 1.33). Forty two (6.6%) deaths from coronary heart disease or stroke occurred in the antioxidant groups compared with 36 (5.7%) in the no antioxidant groups (1.21, 0.78 to 1.89). <b>Conclusion</b> This trial does not provide evidence to support the use of aspirin or antioxidants in primary prevention of cardiovascular events and mortality in the population with diabetes studied. <b>Trial registration</b> Current Controlled Trials ISRCTN53295293.
Few data document current cardiovascular (CV) event rates in stable patients with atherothrombosis in a community setting. Differential event rates for patients with documented coronary artery disease (CAD), cerebrovascular disease … Few data document current cardiovascular (CV) event rates in stable patients with atherothrombosis in a community setting. Differential event rates for patients with documented coronary artery disease (CAD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) or those at risk of these diseases have not been previously evaluated in a single international cohort.To establish contemporary, international, 1-year CV event rates in outpatients with established arterial disease or with multiple risk factors for atherothrombosis.The Reduction of Atherothrombosis for Continued Health (REACH) Registry is an international, prospective cohort of 68 236 patients with either established atherosclerotic arterial disease (CAD, PAD, CVD; n = 55 814) or at least 3 risk factors for atherothrombosis (n = 12 422), who were enrolled from 5587 physician practices in 44 countries in 2003-2004.Rates of CV death, myocardial infarction (MI), and stroke.As of July 2006, 1-year outcomes were available for 95.22% (n = 64 977) of participants. Cardiovascular death, MI, or stroke rates were 4.24% overall: 4.69% for those with established atherosclerotic arterial disease vs 2.15% for patients with multiple risk factors only. Among patients with established disease, CV death, MI, or stroke rates were 4.52% for patients with CAD, 6.47% for patients with CVD, and 5.35% for patients with PAD. The incidences of the end point of CV death, MI, or stroke or of hospitalization for atherothrombotic event(s) were 15.20% for CAD, 14.53% for CVD, and 21.14% for PAD patients with established disease. These event rates increased with the number of symptomatic arterial disease locations, ranging from 5.31% for patients with risk factors only to 12.58% for patients with 1, 21.14% for patients with 2, and 26.27% for patients with 3 symptomatic arterial disease locations (P<.001 for trend).In this large, contemporary, international study, outpatients with established atherosclerotic arterial disease, or at risk of atherothrombosis, experienced relatively high annual CV event rates. Multiple disease locations increased the 1-year risk of CV events.
Abstract —Peripheral arterial disease (PAD) in the legs, measured noninvasively by the ankle-arm index (AAI) is associated with clinically manifest cardiovascular disease (CVD) and its risk factors. To determine risk … Abstract —Peripheral arterial disease (PAD) in the legs, measured noninvasively by the ankle-arm index (AAI) is associated with clinically manifest cardiovascular disease (CVD) and its risk factors. To determine risk of total mortality, coronary heart disease, or stroke mortality and incident versus recurrent CVD associated with a low AAI, we examined the relationship of the AAI to subsequent CVD events in 5888 older adults with and without CVD. The AAI was measured in 5888 participants ≥65 years old at the baseline examination of the Cardiovascular Health Study. All participants had a detailed assessment of prevalent CVD and were contacted every 6 months for total mortality and CVD events (including CVD mortality, fatal and nonfatal myocardial infarction, congestive heart failure, angina, stroke, and hospitalized PAD). The crude mortality rate at 6 years was highest (32.3%) in those participants with prevalent CVD and a low AAI ( P &lt;0.9), and it was lowest in those with neither of these findings (8.7%, P &lt;0.01). Similar patterns emerged from analysis of recurrent CVD and incident CVD. The risk for incident congestive heart failure (relative risk [RR]=1.61) and for total mortality (RR=1.62) in those without CVD at baseline but with a low AAI remained significantly elevated after adjustment for cardiovascular risk factors. Hospitalized PAD events occurred months to years after the AAI was measured, with an adjusted RR of 5.55 (95% CI, 3.08 to 9.98) in those at risk for incident events. A statistically significant decline in survival was seen at each 0.1 decrement in the AAI. An AAI of &lt;0.9 is an independent risk factor for incident CVD, recurrent CVD, and mortality in this group of older adults in the Cardiovascular Health Study.
The rationale and technic of a new procedure—transluminal recanalization of arterio-sclerotic obstructions—has been described. Of the 11 extremities treated, six have shown marked improvement (four amputations averted). It is reasonable … The rationale and technic of a new procedure—transluminal recanalization of arterio-sclerotic obstructions—has been described. Of the 11 extremities treated, six have shown marked improvement (four amputations averted). It is reasonable to assume that with a perfected technic and patients with less advanced disease, the percentage of successful recanalizations would increase. Early treatment with this technic may well prevent otherwise serious disease, not just prevent amputation of extremities not suitable for definitive surgery. We are satisfied that percutaneous transluminal recanalization is the treatment of choice for many lesions of the femoral and popliteal arteries. We believe this method is ready for application to obstructions up to approximately 10 cm. by those skilled in the use of vascular catheters. No doubt the interest and ingenuity of others will lead to refinements of technic as well as further clarification of the role of this attack on arteriosclerotic obstructions.
Peripheral arterial disease measured noninvasively by the ankle-arm index (AAI) is common in older adults, largely asymptomatic, and associated with clinically manifest cardiovascular disease (CVD). The criteria for an abnormal … Peripheral arterial disease measured noninvasively by the ankle-arm index (AAI) is common in older adults, largely asymptomatic, and associated with clinically manifest cardiovascular disease (CVD). The criteria for an abnormal AAI have varied in previous studies. To determine whether there is an inverse dose-response relation between the AAI and clinical CVD, subclinical disease, and risk factors, we examined the relation of the AAI to cardiovascular risk factors, other noninvasive measures of subclinical atherosclerosis using carotid ultrasound, echocardiography and electrocardiography, and clinical CVD.The AAI was measured in 5084 participants > or = 65 years old at the baseline examination of the Cardiovascular Health Study. All subjects had detailed assessment of prevalent CVD, measures of cardiovascular risk factors, and noninvasive measures of disease. Participants were stratified by baseline clinical CVD status and AAI (< 0.8, > or = 0.8 to < 0.9, > or = 0.9 to < 1.0, > or = 1.0 to < 1.5). Analyses tested for a dose-response relation of the AAI with clinical CVD, risk factors, and subclinical disease. The cumulative frequency of a low AAI was 7.4% of participants < 0.8, 12.4% < 0.9, and 23.6% < 1.0. participants with an AAI < 0.8 were more than twice as likely as those with an AAI of 1.0 to 1.5 to have a history of myocardial infarction, angina, congestive heart failure, stroke, or transient ischemic attack (all P < .01). In participants free of clinical CVD at baseline, the AAI was inversely related to history of hypertension, history of diabetes, and smoking, as well as systolic blood pressure, serum creatinine, fasting glucose, fasting insulin, measures of pulmonary function, and fibrinogen level (all P < .01). Risk factor associations with the AAI were similar in men and women free of CVD except for serum total and low-density lipoprotein cholesterol, which were inversely associated with AAI level only in women. Risk factors associated with an AAI of < 1.0 in multivariate analysis included smoking (odds ratio [OR], 2.55), history of diabetes (OR, 3.84), increasing age (OR, 1.54), and nonwhite race (OR, 2.36). In the 3372 participants free of clinical CVD, other noninvasive measures of subclinical CVD, including carotid stenosis by duplex scanning, segmental wall motion abnormalities by echocardiogram, and major ECG abnormalities were inversely related to the AAI (all P < .01).There was an inverse dose-response relation of the AAI with CVD risk factors and subclinical and clinical CVD among older adults. The lower the AAI, the greater the increase in CVD risk; however, even those with modest, asymptomatic reductions in the AAI (0.8 to 1.0) appear to be at increased risk of CVD.
The clinical management of acute myocardial infarc- tion and crescendo angina as well as the prevention of sudden ischaemic death require accurate knowledge of the underlying arterial pathology.It is on … The clinical management of acute myocardial infarc- tion and crescendo angina as well as the prevention of sudden ischaemic death require accurate knowledge of the underlying arterial pathology.It is on just this aspect that until recently there has been disagreement particularly among pathologists.In brief, this con- troversy was concerned with whether coronary artery thrombi were or were not directly responsible for all three clinical pictures of acute ischaemia.Resolution of the controversy has been derived from coronary angiography in life in patients with acute infarction and crescendo angina and from detailed pathological studies.These latter studies dif- fer from many carried out previously by the use of postmortem coronary angiography and histological reconstruction of the microanatomy of occlusive lesions.
ContextSeveral novel risk factors for atherosclerosis have recently been proposed, but few comparative data exist to guide clinical use of these emerging biomarkers.ObjectiveTo compare the predictive value of 11 lipid … ContextSeveral novel risk factors for atherosclerosis have recently been proposed, but few comparative data exist to guide clinical use of these emerging biomarkers.ObjectiveTo compare the predictive value of 11 lipid and nonlipid biomarkers as risk factors for development of symptomatic peripheral arterial disease (PAD).Design, Setting, and ParticipantsNested case-control study using plasma samples collected at baseline from a prospective cohort of 14 916 initially healthy US male physicians aged 40 to 84 years, of whom 140 subsequently developed symptomatic PAD (cases); 140 age- and smoking status–matched men who remained free of vascular disease during an average 9-year follow-up period were randomly selected as controls.Main Outcome MeasureIncident PAD, as determined by baseline total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol–HDL-C ratio, triglycerides, homocysteine, C-reactive protein (CRP), lipoprotein(a), fibrinogen, and apolipoproteins (apo) A-I and B-100.ResultsIn univariate analyses, plasma levels of total cholesterol (P&lt;.001), LDL-C (P = .001), triglycerides (P = .001), apo B-100 (P = .001), fibrinogen (P = .02), CRP (P = .006), and the total cholesterol–HDL-C ratio (P&lt;.001) were all significantly higher at baseline among men who subsequently developed PAD compared with those who did not, while levels of HDL-C (P = .009) and apo A-I (P = .05) were lower. Nonsignificant baseline elevations of lipoprotein(a) (P = .40) and homocysteine (P = .90) were observed. In multivariable analyses, the total cholesterol–HDL-C ratio was the strongest lipid predictor of risk (relative risk [RR] for those in the highest vs lowest quartile, 3.9; 95% confidence interval [CI], 1.7-8.6), while CRP was the strongest nonlipid predictor (RR for the highest vs lowest quartile, 2.8; 95% CI, 1.3-5.9). In assessing joint effects, addition of CRP to standard lipid screening significantly improved risk prediction models based on lipid screening alone (P&lt;.001).ConclusionsOf 11 atherothrombotic biomarkers assessed at baseline, the total cholesterol–HDL-C ratio and CRP were the strongest independent predictors of development of peripheral arterial disease. C-reactive protein provided additive prognostic information over standard lipid measures.
Because patients with peripheral arterial disease (PAD) may be asymptomatic or may present with atypical symptoms or findings, the true population prevalence of PAD is essentially unknown. We used four … Because patients with peripheral arterial disease (PAD) may be asymptomatic or may present with atypical symptoms or findings, the true population prevalence of PAD is essentially unknown. We used four highly reliable, sophisticated noninvasive tests (segmental blood pressure, flow velocity by Doppler ultrasound, postocclusive reactive hyperemia, and pulse reappearance half-time) to assess the prevalence of large-vessel PAD and small-vessel PAD in an older (average age 66 years) defined population of 613 men and women. A total of 11.7% of the population had large-vessel PAD on noninvasive testing, and nearly half of those with large-vessel PAD also had small-vessel PAD (5.2%). An additional 16.0% of the population had isolated small-vessel PAD. Large-vessel PAD increased dramatically with age and was slightly more common in men and in subjects with hyperlipidemia. Isolated small-vessel PAD, by contrast, was essentially unrelated to sex, hyperlipidemia, or age, although it was somewhat less common before age 60. Intermittent claudication rates in this population were 2.2% in men and 1.7% in women, and abnormalities in femoral or posterior tibial pulse were present in 20.3% of men and 22.1% of women compared with the noninvasively assessed large-vessel PAD rate of 11.7%. Thus assessment of large-vessel PAD prevalence by intermittent claudication dramatically underestimated the true large-vessel PAD prevalence and assessment by peripheral pulse examination dramatically overestimated the true prevalence.
Persons with lower-extremity peripheral arterial disease (PAD) are often asymptomatic or have leg symptoms other than intermittent claudication (IC).To identify clinical characteristics and functional limitations associated with a broad range … Persons with lower-extremity peripheral arterial disease (PAD) are often asymptomatic or have leg symptoms other than intermittent claudication (IC).To identify clinical characteristics and functional limitations associated with a broad range of leg symptoms identified among patients with PAD.Cross-sectional study of 460 men and women with PAD and 130 without PAD, who were identified consecutively, conducted between October 1998 and January 2000 at 3 Chicago-area medical centers.Ankle-brachial index score of less than 0.90; scores from 6-minute walk, accelerometer-measured physical activity over 7 days, repeated chair raises, standing balance (full tandem stand), 4-m walking velocity, San Diego claudication questionnaire, Geriatric Depression Score Short-Form, and the Walking Impairment Questionnaire.All groups with PAD had poorer functioning than participants without PAD. The following values are for patients without IC vs those with IC. Participants in the group with leg pain on exertion and rest (n = 88) had a higher (poorer) score for neuropathy (5.6 vs 3.5; P<.001), prevalence of diabetes mellitus (48.9% vs 26.7%; P<.001), and spinal stenosis (20.8% vs 7.2%; P =.002). The atypical exertional leg pain/carry on group (exertional leg pain other than IC associated with walking through leg pain [n = 41]) and the atypical exertional leg pain/stop group (exertional leg pain other than IC that causes one to stop walking [n = 90]) had better functioning than the IC group. The group without exertional leg pain/inactive (no exertional leg pain in individual who walks </=6 blocks per week [n = 28]) and the leg pain on exertion and rest group had poorer functioning than those with IC. Adjusting for age, sex, race, and comorbidities and compared with IC, participants with atypical exertional leg pain/carry on achieved a greater distance on the 6-minute walk (404.3 vs 328.5 m; P<.001) and were less likely to stop during the 6-minute walk (6.8% vs 36%; P =.002). The group with pain on exertion and rest had a slower time for completing 5 chair raises (13.5 vs 11.9 seconds; P =.009), completed the tandem stand less frequently (37.5% vs 60.0%; P =.004), and had a slower 4-m walking velocity (0.80 vs 0.90 m/s; P<.001).There is a wide range of leg symptoms in persons with PAD beyond that of classic IC. Comorbid disease may contribute to these symptoms in PAD. Functional impairments are found in every PAD symptom group, and the degree of functional limitation varies depending on the type of leg symptom.
Background— Peripheral arterial disease (PAD) is associated with significant morbidity and mortality and is an important marker of subclinical coronary heart disease. However, estimates of PAD prevalence in the general … Background— Peripheral arterial disease (PAD) is associated with significant morbidity and mortality and is an important marker of subclinical coronary heart disease. However, estimates of PAD prevalence in the general US population have varied widely. Methods and Results— We analyzed data from 2174 participants aged 40 years and older from the 1999–2000 National Health and Nutrition Examination Survey. PAD was defined as an ankle-brachial index &lt;0.90 in either leg. The prevalence of PAD among adults aged 40 years and over in the United States was 4.3% (95% CI 3.1% to 5.5%), which corresponds to ≈5 million individuals (95% CI 4 to 7 million). Among those aged 70 years or over, the prevalence was 14.5% (95% CI 10.8% to 18.2%). In age- and gender-adjusted logistic regression analyses, black race/ethnicity (OR 2.83, 95% CI 1.48 to 5.42) current smoking (OR 4.46, 95% CI 2.25 to 8.84), diabetes (OR 2.71, 95% CI 1.03 to 7.12), hypertension (OR 1.75, 95% CI 0.97 to 3.13), hypercholesterolemia (OR 1.68, 95% CI 1.09 to 2.57), and low kidney function (OR 2.00, 95% CI 1.08 to 3.70) were positively associated with prevalent PAD. More than 95% of persons with PAD had 1 or more cardiovascular disease risk factors. Elevated fibrinogen and C-reactive protein levels were also associated with PAD. Conclusions— This study provides nationally representative prevalence estimates of PAD in the United States, revealing that PAD affects more than 5 million adults. PAD prevalence increases dramatically with age and disproportionately affects blacks. The vast majority of individuals with PAD have 1 or more cardiovascular disease risk factors that should be targeted for therapy.
Background— The associations of low (&lt;0.90) and high (&gt;1.40) ankle brachial index (ABI) with risk of all-cause and cardiovascular disease (CVD) mortality have not been examined in a population-based setting. … Background— The associations of low (&lt;0.90) and high (&gt;1.40) ankle brachial index (ABI) with risk of all-cause and cardiovascular disease (CVD) mortality have not been examined in a population-based setting. Methods and Results— We examined all-cause and CVD mortality in relation to low and high ABI in 4393 American Indians in the Strong Heart Study. Participants had bilateral ABI measurements at baseline and were followed up for 8.3±2.2 years (36 589 person-years). Cox regression was used to quantify mortality rates among participants with high and low ABI relative to those with normal ABI (0.90 ≤ABI ≤1.40). Death from all causes occurred in 1022 participants (23.3%; 27.9 deaths per 1000 person-years), and of these, 272 (26.6%; 7.4 deaths per 1000 person-years) were attributable to CVD. Low ABI was present in 216 participants (4.9%), and high ABI occurred in 404 (9.2%). Diabetes, albuminuria, and hypertension occurred with greater frequency among persons with low (60.2%, 44.4%, and 50.1%) and high (67.8%, 49.9%, and 45.1%) ABI compared with those with normal ABI (44.4%, 26.9%, and 36.5%), respectively ( P &lt;0.0001). Adjusted risk estimates for all-cause mortality were 1.69 (1.34 to 2.14) for low and 1.77 (1.48 to 2.13) for high ABI, and estimates for CVD mortality were 2.52 (1.74 to 3.64) for low and 2.09 (1.49 to 2.94) for high ABI. Conclusions— The association between high ABI and mortality was similar to that of low ABI and mortality, highlighting a U-shaped association between this noninvasive measure of peripheral arterial disease and mortality risk. Our data suggest that the upper limit of normal ABI should not exceed 1.40.
HomeCirculationVol. 94, No. 11Diagnosis and Treatment of Chronic Arterial Insufficiency of the Lower Extremities: A Critical Review HomeCirculationVol. 94, No. 11Diagnosis and Treatment of Chronic Arterial Insufficiency of the Lower Extremities: A Critical Review
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2D : two-dimensional 3D : three-dimensional ABI : ankle–brachial index ACAS : Asymptomatic Carotid Atherosclerosis Study ACCF : American College of Cardiology Foundation ACE : angiotensin-converting enzyme ACS : acute … 2D : two-dimensional 3D : three-dimensional ABI : ankle–brachial index ACAS : Asymptomatic Carotid Atherosclerosis Study ACCF : American College of Cardiology Foundation ACE : angiotensin-converting enzyme ACS : acute coronary syndrome ACST : Asymptomatic Carotid Surgery Trial ALI : acute limb ischaemia ASTRAL : Angioplasty and Stenting for Renal Artery Lesions trial BASIL : Bypass versus Angioplasty in Severe Ischaemia of the Leg BOA : Dutch Bypass Oral Anticoagulants or Aspirin CABG : coronary artery bypass grafting CAD : coronary artery disease CAPRIE : Clopidogrel versus Aspirin in Patients at Risk for Ischaemic Events CAPTURE : Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events CARP : Coronary Artery Revascularization Prophylaxis CAS : carotid artery stenting CASPAR : Clopidogrel and Acetylsalicylic Acid in Bypass Surgery for Peripheral Arterial Disease CASS : Coronary Artery Surgery Study CAVATAS : CArotid and Vertebral Artery Transluminal Angioplasty Study CEA : carotid endarterectomy CHARISMA : Clopidogrel for High Atherothrombotic Risk and Ischaemic Stabilization, Management and Avoidance CI : confidence interval CLEVER : Claudication: Exercise Versus Endoluminal Revascularization CLI : critical limb ischaemia CORAL : Cardiovascular Outcomes in Renal Atherosclerotic Lesions COURAGE : Clinical Outcomes Utilization Revascularization and Aggressive Drug Evaluation CPG : Committee for Practice Guidelines CREST : Carotid Revascularization Endarterectomy vs. Stenting Trial CT : computed tomography CTA : computed tomography angiography CVD : cardiovascular disease DECREASE-V : Dutch Echocardiographic Cardiac Risk Evaluation DRASTIC : Dutch Renal Artery Stenosis Intervention Cooperative Study DSA : digital subtraction angiography DUS : duplex ultrasound/duplex ultrasonography EACTS : European Association for Cardio-Thoracic Surgery EAS : European Atherosclerosis Society ECST : European Carotid Surgery Trial EPD : embolic protection device ESC : European Society of Cardiology ESH : European Society of Hypertension ESRD : end-stage renal disease EUROSCORE : European System for Cardiac Operative Risk Evaluation EVA-3S : Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis EXACT : Emboshield and Xact Post Approval Carotid Stent Trial GALA : General Anaesthesia versus Local Anaesthesia for Carotid Surgery GFR : glomerular filtration rate GRACE : Global Registry of Acute Coronary Events HbA1c : glycated haemoglobin HDL : high-density lipoprotein HOPE : Heart Outcomes Prevention Evaluation HR : hazard ratio IC : intermittent claudication ICSS : International Carotid Stenting Study IMT : intima–media thickness ITT : intention to treat LDL : low-density lipoprotein LEAD : lower extremity artery disease MACCEs : major adverse cardiac and cerebrovascular events MDCT : multidetector computed tomography MONICA : Monitoring of Trends and Determinants in Cardiovascular Disease MRA : magnetic resonance angiography MRI : magnetic resonance imaging NASCET : North American Symptomatic Carotid Endarterectomy Trial ONTARGET : Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial OR : odds ratio PAD : peripheral artery diseases PARTNERS : Peripheral Arterial Disease Awareness, Risk, and Treatment: New Resources for Survival PCI : percutaneous coronary intervention PET : positron emission tomography PRO-CAS : Predictors of Death and Stroke in CAS PTA : percutaneous transluminal angioplasty RAAS : renin–angiotensin–aldosterone system RADAR : Randomized, Multicentre, Prospective Study Comparing Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting in Patients With Haemodynamically Relevant Atherosclerotic Renal Artery Stenosis RAS : renal artery stenosis RCT : randomized controlled trial REACH : Reduction of Atherothrombosis for Continued Health RR : risk ratio SAPPHIRE : Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy SCAI : Society for Cardiovascular Angiography and Interventions SIR : Society of Interventional Radiology SPACE : Stent-Protected Angioplasty versus Carotid Endarterectomy SPARCL : Stroke Prevention by Aggressive Reduction in Cholesterol Levels Study STAR : Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function SSYLVIA : Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries SVMB : Society for Vascular Medicine and Biology TASC : TransAtlantic Inter-Society Consensus TIA : transient ischaemic attack UEAD : upper extremity artery disease VA : vertebral artery Guidelines summarize and evaluate all available evidence, at the time of the writing process, on a particular issue with the aim of assisting physicians in selecting the best management strategies for an individual patient, with a given condition, taking into account the impact on outcome, as well as the risk–benefit ratio of particular diagnostic or therapeutic means. Guidelines are no substitutes but are complements for textbooks and cover the ESC Core Curriculum topics. Guidelines and recommendations should help the physicians to make decisions in their daily practice. However, the final decisions concerning an individual patient must be made by the responsible physician(s). A large number of Guidelines have been issued in recent years by the European Society of Cardiology (ESC) as well as by other societies and organizations. Because of the impact on clinical practice, quality criteria for the development of guidelines have been established in order to make all decisions transparent to the user. The recommendations for formulating and issuing ESC Guidelines can be found on the ESC website (http://www.escardio.org/guidelines-surveys/esc-guidelines/about/Pages/rules-writing.aspx). ESC Guidelines represent the official position of the ESC on a given topic and are regularly updated. Members of this Task Force were selected by the ESC to represent professionals involved with the medical care of patients with this pathology. Selected experts in the field undertook a comprehensive review of the published evidence for diagnosis, management, and/or prevention of a given condition according to ESC Committee for Practice Guidelines (CPG) policy. A critical evaluation of diagnostic and therapeutic procedures was performed including assessment of the risk–benefit ratio. Estimates of expected health outcomes for larger populations were included, where data exist. The level of evidence and the strength of recommendation of particular treatment options were weighed and graded according to pre-defined scales, as outlined in Tables 1 and 2 . …
ERIPHERAL ARTERIAL DISEASE2][3][4][5] A regional pilot study of community screening for PAD demonstrated that patient awareness of the PAD diagnosis was low and associated with low atherosclerosis risk factor, antiplatelet, … ERIPHERAL ARTERIAL DISEASE2][3][4][5] A regional pilot study of community screening for PAD demonstrated that patient awareness of the PAD diagnosis was low and associated with low atherosclerosis risk factor, antiplatelet, and claudication treatment intensity. 5There have been no national efforts in the United States to detect PAD in communitybased office practice, to assess both physician and patient awareness of the diagnosis, or to assess the intensity of medical treatments.PAD has not emerged as a focus of public health ef-
New data on the epidemiology of peripheral artery disease (PAD) are available, and they should be integrated with previous data. We provide an updated, integrated overview of the epidemiology of … New data on the epidemiology of peripheral artery disease (PAD) are available, and they should be integrated with previous data. We provide an updated, integrated overview of the epidemiology of PAD, a focused literature review was conducted on the epidemiology of PAD. The PAD results were grouped into symptoms, diagnosis, prevalence, and incidence both in the United States and globally, risk factors, progression, coprevalence with other atherosclerotic disease, and association with incident cardiovascular morbidity and mortality. The most common symptom of PAD is intermittent claudication, but noninvasive measures, such as the ankle-brachial index, show that asymptomatic PAD is several times more common in the population than intermittent claudication. PAD prevalence and incidence are both sharply age-related, rising >10% among patients in their 60s and 70s. With aging of the global population, it seems likely that PAD will be increasingly common in the future. Prevalence seems to be higher among men than women for more severe or symptomatic disease. The major risk factors for PAD are similar to those for coronary and cerebrovascular disease, with some differences in the relative importance of factors. Smoking is a particularly strong risk factor for PAD, as is diabetes mellitus, and several newer risk markers have shown independent associations with PAD. PAD is strongly associated with concomitant coronary and cerebrovascular diseases. After adjustment for known cardiovascular disease risk factors, PAD is associated with an increased risk of incident coronary and cerebrovascular disease morbidity and mortality.
The catheter method of angiography has become more popular in the past few years, as it provides the following advantages over the method of injecting the contrast medium by means … The catheter method of angiography has become more popular in the past few years, as it provides the following advantages over the method of injecting the contrast medium by means of a simple needle: 1. The contrast medium may be injected into a vessel at any level desired. 2. Risk of extravascular injection of the contrast medium is minimised. 3. The patient may be placed in any position required. 4. The catheter may be left in situ without risk while the films are being developed, thus facilitating re-examination if necessary. Until recently, however, the use of the catheter method was restricted because of the lack of a suitable flexible thin-walled catheter which could be
Intermittent claudication has been studied in cardiovascular surveys but limited information is available on asymptomatic peripheral arterial disease. The purpose of this paper is to describe the prevalence of both … Intermittent claudication has been studied in cardiovascular surveys but limited information is available on asymptomatic peripheral arterial disease. The purpose of this paper is to describe the prevalence of both asymptomatic and symptomatic disease and relation to ischaemic heart disease in the Edinburgh Artery Study. A cross-sectional survey was conducted on an age-stratified sample of men and women aged 55 to 74 years selected from age-sex registers in ten general practices in the city. Arterial disease was assessed in 1592 participants by means of the WHO questionnaire on intermittent claudication and measurement of the ankle brachial systolic pressure index (ABPI) and change in ankle systolic pressure during reactive hyperaemla. The prevalence of intermittent claudication was 4.5% (95% confidence interval (CI): 3.5%–5.5%). Major asymptomatic disease causing a significant impairment of blood flow occurred in 8.0% (95% CI: 6.6%–9.4%). A further 16.6% (95% Cl: 14.6%–18.5%) had criteria considered abnormal in clinical practice: 9.0% had ABPI <0.9 and 7.6% had reactive hyperaemia pressure reduction >20%. Intermittent claudication was equally common in both sexes. The ABPI and reactive hyperaemia results suggested a slight preponderance of asymptomatic disease in males and were consistent with an increasing prevalence with age and lower social class. Mean ABPI was higher in normal men than women, and was lower in the left leg than the right suggesting a unilateral predisposition to disease. Subjects with major asymptomatic disease had more evidence of ischaemic heart disease than in the normal population (relative risk (RR) 1.6; 95% CI: 1.3–1.9). In conclusion, major esymptomatic atherosclerosis affecting the lower limbs occurs commonly in the general population and is associated with ischaemic heart disease such that further study is required of natural history and prospects for prevention of major vascular events.
Previous investigators have observed a doubling of the mortality rate among patients with intermittent claudication, and we have reported a fourfold increase in the overall mortality rate among subjects with … Previous investigators have observed a doubling of the mortality rate among patients with intermittent claudication, and we have reported a fourfold increase in the overall mortality rate among subjects with large-vessel peripheral arterial disease, as diagnosed by noninvasive testing. In this study, we investigated the association of large-vessel peripheral arterial disease with rates of mortality from all cardiovascular diseases and from coronary heart disease.
Peripheral arterial disease, which is caused by atherosclerotic occlusion of the arteries to the legs, is an important manifestation of systemic atherosclerosis. The age-adjusted prevalence of peripheral arterial disease is … Peripheral arterial disease, which is caused by atherosclerotic occlusion of the arteries to the legs, is an important manifestation of systemic atherosclerosis. The age-adjusted prevalence of peripheral arterial disease is approximately 12 percent, and the disorder affects men and women equally (Table 1).7,8 Patients with peripheral arterial disease, even in the absence of a history of myocardial infarction or ischemic stroke, have approximately the same relative risk of death from cardiovascular causes as do patients with a history of coronary or cerebrovascular disease (Table 2).12,15 In patients with peripheral arterial disease, the rate of death from all causes . . .
Because stent implantation for disease of the superficial femoral artery has been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is preferred for endovascular treatment, and stenting … Because stent implantation for disease of the superficial femoral artery has been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is preferred for endovascular treatment, and stenting is recommended only in the event of suboptimal technical results. We evaluated whether primary implantation of a self-expanding nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.We randomly assigned 104 patients who had severe claudication or chronic limb ischemia due to stenosis or occlusion of the superficial femoral artery to undergo primary stent implantation (51 patients) or angioplasty (53 patients). Restenosis and clinical outcomes were assessed at 6 and 12 months.The mean (+/-SD) length of the treated segment was 132+/-71 mm in the stent group and 127+/-55 mm in the angioplasty group. Secondary stenting was performed in 17 of 53 patients (32 percent) in the angioplasty group, in most cases because of a suboptimal result after angioplasty. At 6 months, the rate of restenosis on angiography was 24 percent in the stent group and 43 percent in the angioplasty group (P=0.05); at 12 months the rates on duplex ultrasonography were 37 percent and 63 percent, respectively (P=0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group.In the intermediate term, treatment of superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting. (ClinicalTrials.gov number, NCT00281060.).
Hospital studies were used to identify those characteristics of angina pectoris, cardiac infarction and intermittent claudication which most effectively distinguish these conditions from other causes of chest or leg pain. … Hospital studies were used to identify those characteristics of angina pectoris, cardiac infarction and intermittent claudication which most effectively distinguish these conditions from other causes of chest or leg pain. These are used to formulate precise definitions for epidemiological use and to form the basis of a standardized questionnaire.Agreement on the use of such a questionnaire would permit international comparisons of the prevalence of these conditions, as defined. This would not hinder the collection of additional information, as required in particular studies.As compared with physicians' diagnoses, the questionnaire had high specificity and reasonably good sensitivity. Interpretation of subjects' answers presents no serious difficulties. There is evidence that the diagnosis of angina pectoris presents special problems in populations with a high prevalence of chronic bronchitis.
Background Several randomized controlled trials ( RCT s) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity … Background Several randomized controlled trials ( RCT s) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta-analysis of RCT s investigating paclitaxel-coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all-cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCT s with 4663 patients (89% intermittent claudication) were analyzed. All-cause patient death at 1 year (28 RCT s with 4432 cases) was similar between paclitaxel-coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72-1.61). All-cause death at 2 years (12 RCT s with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15-2.47; -number-needed-to-harm, 29 patients [95% CI , 19-59]). All-cause death up to 5 years (3 RCT s with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI , 1.27-2.93; -number-needed-to-harm, 14 patients [95% CI , 9-32]). Meta-regression showed a significant relationship between exposure to paclitaxel (dose-time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg-year; P<0.001). Trial sequential analysis excluded false-positive findings with 99% certainty (2-sided α, 1.0%). Conclusions There is increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration URL : www.crd.york.ac.uk/PROSPERO . Unique identifier: CRD 42018099447.
BackgroundPeripheral artery disease is a major cardiovascular disease that affected 202 million people worldwide in 2010. In the past decade, new epidemiological data on peripheral artery disease have emerged, enabling … BackgroundPeripheral artery disease is a major cardiovascular disease that affected 202 million people worldwide in 2010. In the past decade, new epidemiological data on peripheral artery disease have emerged, enabling us to provide updated estimates of the prevalence and risk factors for peripheral artery disease globally and regionally and, for the first time, nationally.MethodsFor this systematic review and analysis, we did a comprehensive literature search for studies reporting on the prevalence of peripheral artery disease in the general population that were published between Jan 1, 2011, and April 30, 2019, in PubMed, MEDLINE, Embase, the Global Health database, CINAHL, the Global Health Library, the Allied and Complementary Medicine Database, and ProQuest Dissertations and Theses Global. We also included the Global Peripheral Artery Disease Study of 2013 and the China Peripheral Artery Disease Study as sources. Peripheral artery disease had to be defined as an ankle–brachial index lower than or equal to 0·90. With a purpose-built data collection form, data on study characteristics, sample characteristics, prevalence, and risk factors were abstracted from all the included studies identified from the sources. Age-specific and sex-specific prevalence of peripheral artery disease was estimated in both high-income countries (HICs) and low-income and middle-income countries (LMICs). We also did random-effects meta-analyses to pool the odds ratios of 30 risk factors for peripheral artery disease in HICs and LMICs. UN population data were used to generate the number of people affected by the disease in 2015. Finally, we derived the regional and national numbers of people with peripheral artery disease on the basis of a risk factor-based model.FindingsWe included 118 articles for systematic review and analysis. The prevalence of peripheral artery disease increased consistently with age. At younger ages, prevalence was slightly higher in LMICs than HICs (4·32%, 95% CI 3·01–6·29, vs 3·54%, 1·17–10·24, at 40–44 years), but the increase with age was greater in HICs than LMICs, leading to a higher prevalence in HICs than LMICs at older ages (21·24%, 15·22–28·90, vs 12·04%, 8·67–16·60, at 80–84 years). In HICs, prevalence was slightly higher in women than in men up to age 75 years (eg, 7·81%, 3·97–14·77, vs 6·60%, 3·74–11·38, at 55–59 years), whereas in LMICs little difference was found between women and men (eg, 6·40%, 5·06–8·05, vs 6·37%, 4·74–8·49, at 55–59 years). Overall, the global prevalence of peripheral artery disease in people aged 25 years and older was 5·56%, 3·79–8·55, and the prevalence estimate was higher in HICs than that in LMICs (7·37%, 4·35–13·66, vs 5·09%, 3·64–7·24). Smoking, diabetes, hypertension, and hypercholesterolaemia were major risk factors for peripheral artery disease. Globally, a total of 236·62 million people aged 25 years and older were living with peripheral artery disease in 2015, among whom 72·91% were in LMICs. The Western Pacific Region had the most peripheral artery disease cases (74·08 million), whereas the Eastern Mediterranean Region had the least (14·67 million). More than two thirds of the global peripheral artery disease cases were concentrated in 15 individual countries in 2015.InterpretationPeripheral artery disease continues to become an increasingly serious public health problem, especially in LMICs. With the demographic trend towards ageing and projected rise in important risk factors, a larger burden of peripheral artery disease is to be expected in the foreseeable future.FundingNone.
The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their … The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their publication.The ESC is not responsible in the event of any contradiction, discrepancy and/or ambiguity between the ESC Guidelines and any other official recommendations or guidelines issued by the relevant public health authorities, in particular in relation to good use of healthcare or therapeutic strategies.Health professionals are encouraged to take the ESC Guidelines fully into account when exercising their clinical judgment, as well as in the determination and the implementation of preventive, diagnostic or therapeutic medical strategies; however, the ESC Guidelines do not override, in any way whatsoever, the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient's health condition and in consultation with that patient and, where appropriate and/or necessary, the patient's caregiver.Nor do the ESC Guidelines exempt health professionals from taking into full and careful consideration the relevant official updated recommendations or guidelines issued by the competent public health authorities, in order to manage each patient's case in light of the scientifically accepted data pursuant to their respective ethical and professional obligations.It is also the health professional's responsibility to verify the applicable rules and regulations relating to drugs and medical devices at the time of prescription.
The clinical outcomes of comparing covered stents (CSs) and drug-coated balloons (DCBs) angioplasty in femoropopliteal artery occlusion remain unknown. This study aimed to evaluate the midterm efficacy of CS and … The clinical outcomes of comparing covered stents (CSs) and drug-coated balloons (DCBs) angioplasty in femoropopliteal artery occlusion remain unknown. This study aimed to evaluate the midterm efficacy of CS and DCB procedures in patients with FPO. All 194 patients were divided into CS (94 patients) and DCB (100 patients) groups in this multicenter retrospective study. The primary end point was primary patency at 24 months, and the secondary end points included freedom from clinically driven target lesion revascularization, limb salvage, major adverse events, and overall survival rates. Propensity score matching analysis was performed to reconfirm the main end points. Compared with the patients in the DCB group, those in the CS group had a lower prevalence of smoking (54.3% versus 74.0%, P=0.004) and diabetes (38.3% versus 66.0%, P<0.001) before propensity score matching. Compared with the DCB procedure, the CS procedure resulted in a significantly greater primary patency at 24 months (74.4% versus 55.8%, P=0.019), with comparable primary patency at 12 months; similar results were obtained after matching. However, there was no difference in terms of clinically driven target lesion revascularization, limb salvage, major adverse events, or overall survival rates. Subgroup analyses confirmed the superior clinical patency of CS in patients with diabetes (P=0.010) and proximal reference vessel diameter ≥5.0 mm (P=0.038). A baseline ankle brachial index <0.40 was likely to be an independent risk factor for restenosis, and a postprocedural ankle brachial index ≥0.80 and the CS used (hazard ratio [HR], 0.54 [95% CI, 0.32-0.91], P=0.021) were potential protective factors for restenosis after multivariate analysis. Compared with the DCB procedure, the CS procedure resulted in greater primary patency at 24 months in complicated femoropopliteal artery occlusion lesions.
The objective. To improve the results of treatment of patients with chronic ischemia of the lower extremities and developing an optimal treatment and diagnostic algorithm for this group of patients. … The objective. To improve the results of treatment of patients with chronic ischemia of the lower extremities and developing an optimal treatment and diagnostic algorithm for this group of patients. Materials and methods. The results of treatment of 218 patients with chronic ischemia of the lower extremities were analyzed, of which 144 patients were operated on, 74 were treated conservatively. There were 136 men, 82 women. The average age was 67±6 years. Diagnostic and examination methods: ultrasound angioscanning, single-photon emission computed tomography, combined with three-phase scintigraphy and computed tomography, consultation with a neurologist and cardiologist, electroneuromyography as prescribed by a neurologist and additional examinations as prescribed by a cardiologist. Control was carried out during control outpatient examinations or during re-hospitalization. The observation period is 6 months. Results. Distribution by degrees of ischemia according to A.V. Pokrovsky had the following: 2A – 57 (26.1%) patients, 2B – 31 (14.2%) patients, 3 – 42 (19.2%) patients, 4 – 88 (40.5%) patients. Open surgical operations were performed in 56 (25.7%), endovascular - 64 (29.4%), hybrid operations - 24 (11.0%), conservative treatment - 40 (18.3%), conservative treatment supplemented with the introduction of plasma-free autoplatelet lysate - 34 (15.6%). In the group of operated patients, there were no significant differences depending on the method of surgical treatment in the early postoperative period and at a follow-up period of 6 months (p0.05). Among patients receiving conservative therapy, the best results at a 6-month follow-up period were observed in patients for whom standard therapy was supplemented with angiogenesis autoplatelet factors (p0.05). 101 patients who underwent electroneuromyography were examined for ischemic neuropathy. Neuropathy was detected in 84 patients. After prescribing neurotropic therapy, relief of neuropathic pain was noted in 69 (80.2%) patients. Conclusion. 1. The multidisciplinary approach we have developed to the diagnosis and treatment of patients with chronic ischemia of the lower extremities allows us to improve the results of their treatment. 2. An expanded range of diagnostic techniques makes it possible to assess risk factors and determine optimal treatment tactics in patients with chronic ischemia of the lower extremities, as well as objectively assess the dynamics of their condition.
Introduction and Objective: The STRIDE trial (NCT04560998) demonstrated that once weekly semaglutide 1.0 mg significantly improved maximum walking distance (MWD) in people with type 2 diabetes (T2D) and symptomatic peripheral … Introduction and Objective: The STRIDE trial (NCT04560998) demonstrated that once weekly semaglutide 1.0 mg significantly improved maximum walking distance (MWD) in people with type 2 diabetes (T2D) and symptomatic peripheral artery disease (PAD) vs. placebo. Whether the benefits are consistent across T2D characteristics has not been described. Methods: The primary outcome in STRIDE, MWD measured on a constant load treadmill at 52 weeks, was analyzed by T2D duration (≥10 vs. &amp;lt;10 years), obesity status (BMI (≥30 vs. &amp;lt;30 kg/m2)), glycemic control (HbA1c (≥7% vs. &amp;lt;7%)), and concomitant T2D medications (SGLT2i or insulin). A mixed model for repeated measurements was employed, incorporating treatment, region, and subgroup as fixed factors, along with the treatment-by-subgroup interaction. Baseline values were used as covariates, all nested within each visit. Results: Among 792 randomized STRIDE participants at baseline, median T2D duration was 12.2 years, BMI 28.7 kg/m2, HbA1c 7.1%, with 35.1% on SGLT2i and 31.7% on insulin. Semaglutide significantly improved MWD regardless of T2D duration, BMI, HbA1c and concomitant SGLT2i or insulin use (Figure). Conclusion: These findings support the efficacy of semaglutide in patients with symptomatic PAD across the spectrum of T2D including non-obese participants and those with HbA1c &amp;lt;7%. Disclosure N. Rasouli: Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Eli Lilly and Company. Research Support; Eli Lilly and Company. E. Guder Arslan: Employee; Novo Nordisk A/S, Sanofi. A. Catarig: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. K. Houlind: Consultant; LeMaitre, Novo Nordisk. B. Ludvik: Research Support; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Advisory Panel; Novo Nordisk, Boehringer-Ingelheim. Speaker's Bureau; Boehringer-Ingelheim. Research Support; Amgen Inc. Speaker's Bureau; AstraZeneca. Research Support; Eli Lilly and Company. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. J. Nordanstig: Advisory Panel; AstraZeneca, Novo Nordisk. Other Relationship; Novo Nordisk. H. Sourij: Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Research Support; Eli Lilly and Company. Advisory Panel; Boehringer-Ingelheim. Speaker's Bureau; Daiichi Sankyo. Advisory Panel; Novo Nordisk A/S. Speaker's Bureau; Novo Nordisk A/S. Advisory Panel; Novartis AG, Amarin Corporation, Amgen Inc. S. Thomas: None. S. Verma: Other Relationship; Various. M.P. Bonaca: Other Relationship; CPC Clinical Research. Funding The STRIDE trial was funded by Novo Nordisk A/S
OBJECTIVE The Semaglutide and Walking Capacity in People with Symptomatic Peripheral Artery Disease and Type 2 Diabetes (STRIDE) trial (NCT04560998) showed that once-weekly subcutaneous semaglutide 1.0 mg significantly improved functional … OBJECTIVE The Semaglutide and Walking Capacity in People with Symptomatic Peripheral Artery Disease and Type 2 Diabetes (STRIDE) trial (NCT04560998) showed that once-weekly subcutaneous semaglutide 1.0 mg significantly improved functional outcomes, symptoms, and quality of life in individuals with symptomatic peripheral artery disease (PAD) and type 2 diabetes. Whether these benefits are consistent across diabetes-related characteristics remains unclear. RESEARCH DESIGN AND METHODS The primary outcome was the ratio to baseline (ETR) in maximum walking distance (MWD), with pain-free walking distance (PFWD) as a key secondary end point. Both were measured at 52 weeks using a constant load treadmill. Subgroup analyses were performed by diabetes duration, BMI, HbA1c, and diabetes medications. A mixed model for repeated measurements was used, incorporating treatment, region, and subgroup as fixed factors, and baseline value as covariate, along with the treatment-by-subgroup interaction. RESULTS Among 792 participants (median diabetes duration 12.2 years, HbA1c 7.1%, and BMI 28.7 kg/m2), 35.1% used sodium–glucose cotransporter 2 inhibitors and 31.7% used insulin. Semaglutide significantly improved MWD regardless of diabetes duration (ETR of 1.15 vs. 1.13 for &amp;lt;10 vs. ≥10 years, P = 0.80), BMI (1.12 vs. 1.16 for &amp;lt;30 vs. ≥30 kg/m2, P = 0.58), HbA1c (1.13 for &amp;lt;7% and ≥7%, P = 0.99), or medication use. Semaglutide also improved PFWD across subgroups (P &amp;gt; 0.1 for all interactions). BMI reduction correlated weakly with MWD improvements and was more pronounced in the controls with higher baseline BMI. Safety outcomes were consistent across subgroups. CONCLUSIONS Semaglutide improved walking function in people with PAD and type 2 diabetes, including nonobese individuals and those with well-controlled HbA1c. Benefits were consistent across BMI and HbA1c categories, supporting effectiveness beyond weight or glycemic changes.
ABSTRACT Background The current study aimed to investigate whether scaffolds or repeat drug‐coated balloons (DCBs) were more effective in preventing recurrent restenosis after repeat endovascular therapy (EVT) for early (within … ABSTRACT Background The current study aimed to investigate whether scaffolds or repeat drug‐coated balloons (DCBs) were more effective in preventing recurrent restenosis after repeat endovascular therapy (EVT) for early (within 12 months) and late (after 12 months) DCB restenosis. Methods This study retrospectively analyzed 234 limbs from 213 consecutive patients who underwent repeat EVT using scaffold ( n = 52) or DCB only ( n = 182) for primary DCB restenosis in femoropopliteal lesions at eight cardiovascular centers across Japan. Repeat EVT for early and late DCB restenosis was performed in 123 and 111 limbs, respectively. Results Following repeat EVT, the freedom from recurrent restenosis rate was significantly higher with scaffolds than with DCBs for early DCB restenosis (81.6% vs. 62.3% at 12 months; p = 0.038), whereas no difference between treatment strategies was observed for late restenosis (80.0% vs. 85.9% at 12 months; p = 0.629). Among those who underwent repeat EVT for early restenosis, age ≤ 75 years (hazard ratio [HR], 2.05; 95% confidence interval [CI], 1.06–3.96; p = 0.031), male sex (HR, 2.12; 95% CI, 1.08–4.20; p = 0.029), and lesion length ≥ 150 mm (HR, 2.43; 95% CI, 1.31–4.52; p = 0.005) were significantly associated with recurrent restenosis, while scaffold use during repeat EVT was significantly associated with decreased recurrent restenosis (HR, 0.38; 95% CI, 0.17–0.81; p = 0.012). Conclusion Given the decreased rates of recurrent restenosis, scaffold implantation for DCB restenosis might be an acceptable strategy, particularly for early DCB restenosis after initial DCB.
ABSTRACT Background Limb ischemia is a serious complication of venoarterial (VA) extracorporeal membrane oxygenation (ECMO), potentially resulting in amputation, rhabdomyolysis, or death. This study aimed to evaluate the effectiveness of … ABSTRACT Background Limb ischemia is a serious complication of venoarterial (VA) extracorporeal membrane oxygenation (ECMO), potentially resulting in amputation, rhabdomyolysis, or death. This study aimed to evaluate the effectiveness of near‐infrared spectroscopy (NIRS) monitoring in the early detection and prevention of limb ischemia in peripheral VA ECMO. Methods We retrospectively reviewed 166 patients who underwent peripheral VA ECMO between January 2018 and December 2022. Patients were categorized into two groups based on the implementation of NIRS monitoring (Before‐NIRS [ n = 83] vs. After‐NIRS [ n = 83]). An inverse probability of treatment weighting (IPTW)‐adjusted analysis was conducted. Results Baseline characteristics were not significantly different between the groups. The ECMO weaning success rate was significantly higher in the After‐NIRS group (45.9% vs. 63.4%, p = 0.026). However, survival to discharge did not differ significantly (31.8% vs. 42.7%, p = 0.174). The incidences of rhabdomyolysis and acute limb ischemia were significantly lower in the After‐NIRS group (10.6% vs. 1.2% and 11.8% vs. 0%, respectively). In the After‐NIRS group, a decrease in NIRS values was observed in three patients, prompting timely placement of distal perfusion catheters. None of these patients developed limb ischemia. Conclusions After the implementation of NIRS monitoring, no cases of limb ischemia were observed. NIRS enables early identification of limb malperfusion, facilitates timely intervention, and reduces unnecessary distal perfusion catheter placement. As a non‐invasive, real‐time monitoring modality, NIRS offers continuous assessment of limb perfusion and plays a valuable role in the early prevention of limb ischemia in patients undergoing peripheral VA ECMO.
Drug-eluting stents in the upper leg (DES-UL) are used to treat diseases of the peripheral vessels that are associated with an increased risk of cardiovascular events and are prevalent in … Drug-eluting stents in the upper leg (DES-UL) are used to treat diseases of the peripheral vessels that are associated with an increased risk of cardiovascular events and are prevalent in industrialized countries such as Germany and the USA. Innovative technologies like DES-UL can bring great benefits to patients, possibly representing the only treatment option. However, they also entail risks since reliable evidence on efficacy/effectiveness and safety are often not available at the beginning of products' life cycles. The aim of the study is to examine utilization of DES-UL in German and US-American hospitals and the development of evidence on efficacy/effectiveness and safety for DES-UL over time. To identify evidence, we conducted a systematic literature search in four biomedical databases (2006–2022) for articles on clinical trials that we categorized by predefined characteristics, including studies' level of evidence (LoE) and population sizes, and the articles' conclusions regarding the technology's efficacy/effectiveness and safety clustered “positive”, “indecisive”, “neutral”, or “negative”. Additionally, we searched for clinical trial registry entries, HTA reports, clinical guidelines, safety notices &amp;amp; recalls, market approval dates, and financing instruments. The utilization of DES-UL was operationalized by annual hospital case numbers. We identified a total of 2,724 publications, of which 123 remained relevant after title/abstract and full text screening. In the early phase of the observation period of DES-UL utilization, the evidence development is characterized by a few articles on studies of low LoE and small population studies. Over time, the body of evidence expands, and articles on studies of high LoE (e.g., RCTs) and larger population sizes were published. Overall, articles with “positive” (n = 41) and “indecisive” (n = 58) conclusions predominate, with especially “positive” conclusions pointing to the efficacy/effectiveness and safety of DES-UL. Overall, utilization of DES-UL in hospitals increased in both Germany and the USA, although not uniformly across all years. An influence of various events on the case numbers' development can be assumed. Health policy makers must ensure that efficacy/effectiveness and safety of technologies are evaluated appropriately. Therefore, robust evidence should be generated and made accessible to clinical and health decision-makers in a timely manner and promptly reflected in clinical guidelines.
The present study provides a thorough trend analysis of the burden of lower extremity peripheral arterial disease (PAD) in China during 1990–2021, based on data from the Global Burden of … The present study provides a thorough trend analysis of the burden of lower extremity peripheral arterial disease (PAD) in China during 1990–2021, based on data from the Global Burden of Disease Study 2021. Lower extremity PAD is an atherosclerotic disease that causes obstruction of blood vessels supplying the legs, presenting as intermittent claudication, rest pain, non - healing wounds, ulcers, or gangrene, and may lead to limb amputation or death due to critical limb ischemia. Our analysis covers prevalence, incidence, mortality, years lived with disability (YLDs), years of life lost (YLLs), and disability - adjusted life years (DALYs). A key finding of this study is from the Age - period - cohort (APC) analysis. It shows that age and period effects are risk factors for the incidence and mortality of PAD, while birth cohort effects have a protective role. Additionally, projections using the Autoregressive Integrated Moving Average (ARIMA) model indicate that the risk of death from PAD will increase for males in the future. Through Joinpoint regression analysis, we delineate the temporal trends. Considering China’s aging population, the growing disease burden from economic progress, and the rapidly changing healthcare landscape, these findings highlight the escalating challenge of PAD. The study’s predictions serve as a warning of the continued rise in PAD incidence and emphasize the urgent need for public health interventions to address the increasing burden.
Background While peripheral artery disease care for claudication aims to improve health status (symptoms, physical function, and quality of life), health status trajectories remain unclear. We aimed to determine health … Background While peripheral artery disease care for claudication aims to improve health status (symptoms, physical function, and quality of life), health status trajectories remain unclear. We aimed to determine health status trajectories and explore baseline factors associated with treatment nonresponsiveness. Methods Data were derived from the PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry of patients with claudication symptoms presenting to vascular specialty clinics across the United States, Australia, and Netherlands. The Peripheral Artery Questionnaire was used to measure the health status at baseline and 3, 6, and 12 months. Latent trajectory modeling enabled the classification of patients into latent Peripheral Artery Questionnaire trajectory subgroups over 12 months. These subgroups were categorized as “responsive” or “nonresponsive,” depending on whether the 12‐month increase in mean Peripheral Artery Questionnaire score was greater than or equal to the clinically meaningful threshold of 10 or not, respectively. Sequential hierarchical multivariable logistic regression assessed baseline factors associated with a nonresponsive versus responsive trajectory. Results The cohort was composed of 1204 patients (62.5% men and aged 67.5±9.4 years). Five latent trajectory subgroups were identified: consistently high (33.3%), high maintained (8.1%), high transient (12.9%), moderate maintained (33.2%), and consistently low response (12.5%) with mean Peripheral Artery Questionnaire improvements of +16.8, +59.4, +7.6, +24.0, and +8.6, respectively. Nonresponsive clinical trajectory was associated with prior cerebrovascular accident, sleep apnea, alcohol use disorder, and worse depressive symptoms. Conclusions Individuals with claudication display heterogenous recovery trajectories. Roughly 25% experienced no health status response at 12 months after treatment, which was associated with medical and psychosocial factors. Further emphasis should be placed on a biopsychosocial model of peripheral artery disease care.
Peripheral Artery Disease (PAD) often occurs in diabetes mellitus patients. PAD can be detected early by measuring the Ankle Brachial Index (ABI). ABI measurement should be important for all DM … Peripheral Artery Disease (PAD) often occurs in diabetes mellitus patients. PAD can be detected early by measuring the Ankle Brachial Index (ABI). ABI measurement should be important for all DM clients and all clients at risk of DM but is often ignored, causing PAD. The purpose of this study was to determine the Ankle Brachial Index (ABI) as a predictor of Peripheral Artery Disease (PAD) in patients with diabetes mellitus. The design of this study was descriptive with an observational study approach. The population in this study were all 113 diabetes mellitus clients in July 2024. The sampling technique used purposive sampling so that 100 people were obtained who met the inclusion and exclusion criteria. The research instrument used a digital tensiometer and observation sheet. Data analysis used frequency distribution. The results showed that the normal ankle brachial index value was 40 people (40%), respondents who experienced moderate PAD were 28 people (28%), mild PAD 16 people (16%), ABI tolerated 15 people (15%), and hardening of the arteries 1 person (1%). Data analysis suggested that almost half of the respondents had ankle brachial index PAD values ​​consisting of moderate PAD and mild PAD. Moderate PAD occurs in obese diabetes mellitus patients and those who have suffered from diabetes mellitus &gt; 5 years, and mild PAD occurs in those who have suffered from diabetes mellitus &gt; 5 years and have a history of hypertension.
Introduction: Assessment of mitochondrial oxygen tension (mitoPO 2 ) is a novel technique for measuring skin perfusion. It is based on the oxygen-dependent quenching of delayed fluorescence of 5-aminolevulinic acid … Introduction: Assessment of mitochondrial oxygen tension (mitoPO 2 ) is a novel technique for measuring skin perfusion. It is based on the oxygen-dependent quenching of delayed fluorescence of 5-aminolevulinic acid (5-ALA), known as the protoporphyrin IX-triple state lifetime technique. This study aimed to determine the tolerability and feasibility of measuring mitoPO 2 in the lower limbs of patients with peripheral arterial disease (PAD) undergoing endovascular therapy. In addition, the study investigated the changes in mitoPO 2 pre- and postoperatively. Materials and Methods: This prospective single-center study included patients with Rutherford stage 4 to 6 scheduled for endovascular therapy. Plasters containing 5-ALA were placed over the tibia and at the lower lateral leg 12 hours before the operation. 5-ALA tolerability was assessed by noting the occurrence of related side effects during application, measurements, and in the 48 hours after removal of the plaster. MitoPO 2 was measured immediately before and after the operation over the tibia at the anterior tibialis muscle and the lateral side of the lower leg, and was followed by transcutaneous oxygen pressure and ankle-brachial index measurements. Results: Ten patients were included in this study. No side effects or adverse events related to 5-ALA were observed. One patient reported weak itching within 48 hours after removing the 5-ALA plaster. MitoPO 2 measurements were feasible in all patients at the tibia and lower leg, but were not feasible on the dorsum of the foot. Postoperatively, a significant drop in mitoPO 2 was detected at the tibia. No significant difference was found in mitoPO 2 levels pre- and postoperative at the lower lateral leg. For transcutaneous oxygen pressure, no significant differences were detected postoperatively. Conclusions: 5-ALA is tolerable and safe in patients with PAD. MitPO 2 measurements at the tibia and lower lateral leg are feasible and capable of detecting changes in perfusion following endovascular therapy. Further research is needed with larger cohorts and longer follow-up to investigate the relationship between mitoPO 2 , oxygen supply, and tissue regeneration. Clinical Impact This study demonstrated the feasibility and safety of mitochondrial oxygen tension (mitoPO 2 ) measurement using 5-aminolevulinic acid (5-ALA) for assessing local skin perfusion in patients with peripheral arterial disease (PAD) undergoing endovascular therapy. Changes in mitoPO 2 post-intervention suggest sensitivity to real-time microvascular and physiological alterations. This technique could potenitally improve overall patient outcomes and wound healing by enhancing patient stratification, treatment planning, perioperative monitoring, and postoperative follow-up.
Background/Objectives: The aim of this study was to investigate quantitative differences in optical coherence tomography angiography (OCTA) between diabetic patients and healthy controls and to identify the early OCTA biomarkers … Background/Objectives: The aim of this study was to investigate quantitative differences in optical coherence tomography angiography (OCTA) between diabetic patients and healthy controls and to identify the early OCTA biomarkers for diabetic macular changes. Methods: Ophthalmological examination and OCTA were performed on two groups of diabetic patients (with and without mild diabetic retinopathy) and healthy controls. Macular, foveal, perifoveal, and parafoveal vessel density (VD) in the superficial capillary plexus (SCP) and deep capillary plexus (DCP), foveal avascular zone (FAZ), and flow area in the choriocapillaris were calculated. Results: A total of 431 eyes of 233 participants were analyzed. The VD in the SCP in the whole macula was the lowest in the DM + DR group and lower than in the DMnoDR group; however, in the fovea, it was the highest in the DM + DR group and higher than in the DMnoDR group. The VD in the SCP in the parafovea was lower in the DM + DR group than in the DMnoDR group, and in the perifovea, it was lower in the DMnoDR group than in the control group. The VD in the DCP in the macula, parafovea, and perifovea was lower in the DM + DR group than in the DMnoDR and control groups. The FAZ and flow areas in the choriocapillaris were smaller in the DM + DR group than in both the DMnoDR and control groups. Conclusions: VD reduction in the SCP and the DCP of the macular and parafoveal regions, as well as in the DCP of the perifoveal region, may indicate progression of diabetic retinopathy from subclinical to clinical stages; however, an increase in the foveal region in the SCP can be a compensatory mechanism. VD reduction in the perifovea and whole macula in the SCP can be a screening factor for subclinical macular changes. FAZ reduction before clinical signs of retinopathy may be an early compensatory vascular mechanism.
ABSTRACT Background and Aim The geriatric nutritional risk index (GNRI) predicts adverse outcomes in chronic diseases, but its prognostic value for major adverse limb events (MALE) in elderly patients with … ABSTRACT Background and Aim The geriatric nutritional risk index (GNRI) predicts adverse outcomes in chronic diseases, but its prognostic value for major adverse limb events (MALE) in elderly patients with peripheral artery disease (PAD) remains unverified; thus, this study aimed to establish the association between GNRI and MALE. Design A multicenter, prospective study. Methods From January 2021 to August 2022, 1200 patients with PAD aged ≥ 60 years were enrolled. Patients were stratified by GNRI value (At‐risk group: ≤ 98 vs. No‐risk group: &gt; 98). Data were analysed through Kaplan–Meier curves, multivariable Cox regression, restricted cubic spline (RCS) modelling, and subgroup analyses. Results Among 1036 completers (13.7% attrition rate), 275 (26.5%) developed MALE during a mean follow‐up of 18.9 ± 8.0 months. Kaplan–Meier analysis demonstrated significantly higher MALE incidence in patients in the At‐risk group (log‐rank p &lt; 0.001). Adjusted Cox models revealed a 45% increased MALE risk in patients in the At‐risk group (HR 1.45, 95% CI 1.12–1.86, p = 0.005). RCS identified a non‐linear L‐shaped relationship ( p = 0.006) with inflection at GNRI = 95: Below 95, each 1‐unit GNRI increase reduced MALE risk by 9% (HR 0.91, 95% CI 0.88–0.95, p &lt; 0.001), while no significant association existed above 95. Subgroup analyses confirmed consistency across subgroups (all p ‐interaction &gt; 0.05). Conclusions GNRI exhibits a non‐linear L‐shaped association with MALE risk in elderly patients with PAD, demonstrating critical prognostic utility below the 95 inflection point. Routine GNRI monitoring should be prioritised for patients with GNRI &lt; 95 to guide preventive interventions. Relevance to Clinical Practice GNRI should be incorporated as a routine risk assessment tool for elderly patients with PAD, with particular vigilance required for those with GNRI &lt; 95. Prioritising nutritional screening and intervention in patients with GNRI &lt; 95 may potentially improve clinical outcomes. Patient or Public Contribution Patients contributed to this study by completing follow‐up assessments. Reporting Method This study followed the STROBE guidelines.
ABSTRACT Background Sirolimus‐coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). However, evidence is limited on the durability of the treatment effect in the longer term. … ABSTRACT Background Sirolimus‐coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). However, evidence is limited on the durability of the treatment effect in the longer term. Aims The aim of our study was to assess the long‐term efficacy and safety of SELUTION SCB in the treatment of the femoropopliteal steno‐occlusive disease. Methods This is a single‐center, all‐comers, observational registry in which 80 consecutive patients undergoing SELUTION SCB‐angioplasty due to femoropopliteal steno‐occlusive lesions were enrolled from February 2021 to March 2022. Assessments through 3 years included: primary patency (primary efficacy outcome), defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4; freedom from clinically‐driven target lesion revascularization (CD‐TLR) and secondary patency, defined as freedom from new restenosis following the CD‐TLR (secondary efficacy outcomes); freedom from major adverse limb events (MALEs, primary composite safety outcome); change in median ankle‐brachial index (ABI) and Rutherford classification (functional outcomes). Results At 3 years, primary patency was 74.7% and freedom from CD‐TLR was 85.3%. The rate of CD‐TLR was 14.7% (11 patients). Among them, one patient experienced a new restenosis (failure of CD‐TLR), therefore secondary patency was 90.9%. Freedom from MALEs was 94.7%. Median ABI increased significantly from 0.4 ± 0.2 at baseline to 0.7 ± 0.3 at 36 months postprocedure, as well as Rutherford classification data improved. Conclusions These 3‐year findings suggest long‐term efficacy and safety of SELUTION SCB in the setting of femoropopliteal steno‐occlusive endovascular treatment. Larger cohorts and randomized controlled trials will be needed to confirm these results.
YU. M. HUPALO , Андрій ГОЛЯЧЕНКО , О. E. Shved +2 more | Вісник соціальної гігієни та організації охорони здоров я України
Purpose: The evaluation of the long-term results after popliteal-pedal bypass in diabetic foot patients. Materials and methods. In this retrospective single-center study between January 2011 and June 2016 were selected … Purpose: The evaluation of the long-term results after popliteal-pedal bypass in diabetic foot patients. Materials and methods. In this retrospective single-center study between January 2011 and June 2016 were selected diabetic patients WIfI 2–3, with chronic limb-threatening ischemia (CLTI) Rutherford III-IV category: men 27 (46,6%), women – 31 (53,4%); average age 68 year ±5,6 year (n=58). Results. The mean preoperative ABPI was 0.4 to 1,2 and depend of Menkenbergs calcinoses. According to preoperative DUS in all patients were detected occlusive-stenotic lesion on BTK arteries, the type of Doppler spectrum curve on the foot arteries blood flow with lower peripheral resistance (RI &lt; 0.83) in 31 (53.4%) patients, blood flow with high peripheral resistance (RI = 1.0) – in 19 (32.8%), pedal artery’s lumen was detected – in 8 (13.8%). ТсРО2 on the foot was (11.2 ±6.2) mm. Hg. The ABPI were used to evaluate the hemodynamic response after operation, was the good determinant technical success and clinical improvement, but we did not find any correlation with preoperative data. Wound healing after the intervention on the foot during 1–2 weeks occurred in 46 (79.3%), repeated intervention including autodermoplasty made wound healed within 1.5-2 months in 7 (12.1%) patients. Conclusions. Limb salvage and CLTI patients survival after open surgery who were not performed major amputation after revascularization were comparable regardless of treatment method.
Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerosis, which might progress due to inflammation. This systematic review assessed the association of specific inflammatory biomarkers with morbidity and mortality … Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerosis, which might progress due to inflammation. This systematic review assessed the association of specific inflammatory biomarkers with morbidity and mortality in PAD patients. MEDLINE and EMBASE databases were systematically searched for studies assessing evidence between inflammatory biomarkers and morbidity and mortality risks in PAD patients. Results were reported as Hazard Ratios (HR), Odds Ratios (OR), or mean and standard deviation. Effect estimates for high-sensitivity C-reactive protein (hs-CRP) were pooled using a random-effects model and respectively displayed in forest plots. The study reviewed a total of 7024 records, out of which 26 studies were included for qualitative synthesis and nine for quantitative synthesis. A total of 4673 patients were analyzed in the meta-analysis. Elevated baseline IL-6 levels were consistently linked to poor outcomes, including loss of patency and composite endpoints, such as major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Tumor necrosis factor-α (TNF-α) and related biomarkers were associated with adverse outcomes like mortality and patency loss. Elevated IL-1 levels predicted worse cardiovascular outcomes and IL-1 receptor antagonist levels indicated recurrence or new lesions post-surgery. Hs-CRP was statistically significantly associated with all-cause mortality and MALE in the pooled analysis. The study highlights the ability of inflammatory biomarkers to predict clinical outcomes in PAD patients. The strength of these associations varies based on the specific biomarker and clinical context.
Summary: Background: To report the clinical outcomes of endovascular therapy in nonagenarians treated for symptomatic peripheral arterial disease (PAD). Patients and methods: This is a retrospective analysis of 81 nonagenarians … Summary: Background: To report the clinical outcomes of endovascular therapy in nonagenarians treated for symptomatic peripheral arterial disease (PAD). Patients and methods: This is a retrospective analysis of 81 nonagenarians (mean age 93±2.4 years) treated by endovascular therapy for chronic limb threatening ischemia (CLTI) or claudication between December 2017 and August 2023. The composite of amputation and/or death (amputation-free survival; AFS) was the primary endpoint. Technical success, mortality, major limb amputation, risk for Major Adverse Cardio-Cerebro-vascular Events (MACCE) and re-intervention during follow-up were additionally analysed. Results: Most patients presented with CLTI (n=75, 93%). Popliteal artery interventions were most frequently performed (n=59, 73%), followed by superficial femoral artery (n=57, 70%), tibial (n=49, 61%), aortoiliac (n=11, 14%) and common femoral artery (n=7, 9%) procedures. The technical success rate was 100% and the in-hospital mortality was 1% (n=1). At 24 months the AFS was 23.5%, while the major amputation and mortality rates were 4.9% and 75.3% respectively. In the same period the rate of MACCE was 74.1% and the freedom from re-intervention rate amounted to 85.2% The cox regression analysis revealed a lower AFS among males (HR:1.8, 95% CI: 1.06–3.03, p=0.03) and a higher risk for MACCE in patients on warfarin (HR:3.1, 95% CI:1.26–7.59, p=0.01). Conclusions: Despite the high technical success and the low amputation rates, a very high mortality rate at follow up was observed among nonagenarians undergoing endovascular procedures for PAD. Male gender and Warfarin administration increased the risk for adverse events.
Introduction and Objective: This study aims to evaluate the diagnostic value of OCTA in DKD confirmed by renal biopsy pathology. Methods: This study employed a multicenter case-control study design. One … Introduction and Objective: This study aims to evaluate the diagnostic value of OCTA in DKD confirmed by renal biopsy pathology. Methods: This study employed a multicenter case-control study design. One hundred patients with type 2 diabetes from 3 hospitals in Beijing were selected and divided into DKD group (63 cases) and non-DKD group (37 cases) based on renal biopsy results. All patients underwent OCTA, digital fundus photography, medical history, and biochemical blood and urine tests. Compare the differences of parameters between two groups, and analyze the diagnostic efficacy of DKD through ROC curve analysis. Results: The study found that OCTA has high sensitivity and specificity in identifying diabetic retinopathy. The combination of OCTA and fundus photography significantly increased the detection rate of diabetic kidney disease, with a diagnostic efficacy greater than 85%. There were significant differences in the foveal arch circularity ratio, shallow and deep layer vascular linear density, shallow and deep layer blood flow perfusion density between the diabetic kidney disease group and the non-DKD group, with AUC values all greater than 70%. Conclusion: OCTA combination with fundus photography can effectively increase the detection rate of diabetic kidney disease. Disclosure L. Zhang: None. X. Zhu: None. T. Wei: None. J. Lu: None.
Introduction and Objective: Although creatinine-cystatin C-based estimated glomerular filtration rate (eGFRcr-cys) may better assess renal function than creatinine-based eGFR (eGFRcr), evidence on their differences with diabetic complications and comorbidities remains … Introduction and Objective: Although creatinine-cystatin C-based estimated glomerular filtration rate (eGFRcr-cys) may better assess renal function than creatinine-based eGFR (eGFRcr), evidence on their differences with diabetic complications and comorbidities remains limited. This study aims to address this gap. Methods: This 2015-2018 nationwide cross-sectional study of Chinese adults (aged 18-74) with diabetes employed multistage sampling. Both eGFRs were calculated using 2021 CKD-EPI equations. eGFRdiff was defined as eGFRcr minus eGFRcr-cys. G-staging reclassification (vs. eGFRcr) included consistent, less severe, and more severe. Vascular complications/comorbidities traits included diabetic retinopathy (evaluated by bilateral fundus photography), albuminuria (UACR ≥30 mg/g), diabetic peripheral neuropathy (Michigan Neuropathy Screening Instrument &amp;gt;2 points), cardiovascular diseases (self-reported), and peripheral arterial disease (diminished or disappeared dorsalis pedis artery or posterior tibial artery pulses). Restricted cubic splines (RCS), weighted ordinal, and multinomial logistic regression models were applied. Results: The study included 48,743 participants (median age: 57.4; 49.9% female). RCS plot illustrated a J-shape association between eGFRdiff and cumulative traits, with odds shifting from negative to positive near zero. Ordinal regression analyses showed that compared with complication-free patients with a consistent G-stage, those reclassified into less severe stages had a lower risk of complications [aOR 0.82 (95%CI: 0.75-0.90)], while those reclassified into more severe stages had an higher risk [1.42 (1.29-1.57)]. Multinomial regression models revealed a progressively stronger association with increased number of traits. Conclusion: These findings underscore the utility of eGFRcr-cys in pinpointing high-risk populations with diabetic vascular complications and comorbidities. Disclosure R. Yu: None. X. Ye: None. Y. Liang: None. X. Hou: None. W. Jia: None. Funding This survey was supported by the Bethune Charitable Foundation. This work was also supported by grants from the Shanghai Science and Technology Committee (grant No. 19692115900 and 17411952600), Shanghai Municipal Key Clinical Specialty, Shanghai Key Discipline of Public Health Grants Award (grant No. GWVI-11.1-20), Shanghai Research Center for Endocrine and Metabolic Diseases (grant No. 2022ZZ01002), National Key Clinical Specialty (grant No. Z155080000004), the Chinese Academy of Engineering (grant No. 2022-XY-08), and Sichuan Science and Technology Program (2024NSFSC1624).
Introduction and Objective: Altered glycemic status and peripheral artery disease/claudication (PADC) may co-occur and increase hospitalization risk. Sedentary behavior (SB) and physical activity (PA) also relate to hospitalization risk, but … Introduction and Objective: Altered glycemic status and peripheral artery disease/claudication (PADC) may co-occur and increase hospitalization risk. Sedentary behavior (SB) and physical activity (PA) also relate to hospitalization risk, but whether this applies equally to those with normoglycemia (NG), prediabetes (PDM), diabetes (DM), and PADC is unclear. Methods: In 12,517 HCHS/SOL participants, survey-weighted mean (SE) age 41.2 (0.3) years, 52.6% female, we studied the association between accelerometer-measured activity (SB; light/LPA; moderate/MPA; vigorous/VPA) and hospitalization, using Anderson &amp; Gill recurrent event models. We tested whether the association differed by baseline glycemic/PADC status: NG/no PADC, n=4497; NG+PADC, n=494; PDM/no PADC, n=3920; PDM+PADC, n=937; DM/no PADC, n=1796; DM+PADC, n=873. We modeled PA/SB continuously and categorically, adjusting for demographic, lifestyle, and clinical factors. Over 11 years of follow-up, participants self-reported 7911 hospitalizations, excluding emergency room only and pregnancy. Results: SB was associated with greater and LPA with lower hospitalization risk in all glycemic/PADC groups, with HR (95% CI) of 1.02 (1.01, 1.03) per 30 min/day SB, and 0.98 (0.96, 0.99) per 30 min/d LPA. Categorical SB and LPA results were similar, but the binary SB-hospitalization association was not significant after adjusting for BMI. MPA was not associated with hospitalization. The VPA-hospitalization association differed by glycemic/PADC status. Within the PADC groups, performing any VPA (vs none) was inversely associated with hospitalization in those with NG, HR 0.48 (0.30, 0.79), and directly associated in those with PDM, HR 1.34 (1.06, 1.71). Conclusion: Less SB and greater LPA are associated with lower hospitalization risk. Ability to perform VPA may be a marker of health among those with vascular and metabolic comorbidities. Disclosure S.K. Alver: None. Y. Mossavar-Rahmani: None. K.R. Evenson: None. C. Cuthbertson: None. K. Matsushita: Other Relationship; Fukuda Denshi. Consultant; RhythmX AI. J. Schrack: Consultant; Edwards Lifesciences, The Villages, Inc. Advisory Panel; BellSant, Inc. D. Sotres-Alvarez: None. L. Gallo: None. J. Carlson: None. J. Cai: None. X. Xue: None. R. Kaplan: None. Funding National Institutes of Health (HHSN268201300001I, N01-HC-65233HHSN268201300004I, N01-HC-65234HHSN268201300002I, N01-HC-65235HHSN268201300003I, N01-HC-65236 HHSN268201300005I, N01-HC-65237R01HL146132T32CA094880)
Introduction and Objective: Diabetic foot ulcers (DFUs) are a severe complication of diabetes mellitus, characterized by impaired wound healing and high rates of chronicity. BB-101, a recombinant thrombomodulin analogue, mimics … Introduction and Objective: Diabetic foot ulcers (DFUs) are a severe complication of diabetes mellitus, characterized by impaired wound healing and high rates of chronicity. BB-101, a recombinant thrombomodulin analogue, mimics thrombomodulin's functions, promoting angiogenesis and fibroblast migration, with potential to enhance wound healing in DFU patients. The primary objectives are to evaluate the safety and tolerability of BB-101 compared with placebo group. Secondary objectives include proportion of subjects with target ulcer that heals within the 4-week treatment period and plasma concentration of BB-101. Methods: This study was a randomized, double-blind, placebo-controlled clinical trial in type 2 DM patients with DFU classified as Wagner grade 1-3, located on the lower leg or foot, with sizes ranging from 0.5-20.0 cm² after debridement. Fifteen participants were randomly assigned to one of three treatment arms: 2 μg/mL BB-101 (low-dose), 20 μg/mL BB-101 (high-dose) or placebo applied to the foot ulcer surface for a treatment duration of 4 weeks, followed by a 2-year follow-up. Weekly photography, quantitative planimetry, and physical examinations documented the ulcer appearance, surface area, and stage. Results: As a result of BB-101 treatment, none of the serious adverse events were attributed to the treatment, and no treatment-emergent adverse events led to dose interruption or withdrawal. Patients in either the low- or high- dose group tested negative for anti-BB-101 antibodies at any visit. The low-dose group showed wound reductions from 1.38-3.03 cm² to complete closure in some cases, while high-dose treatment achieved reductions from 4.39-2.67 cm² to 0.14 cm². Both groups demonstrated consistent and increasing wound tissue proliferation and significant healing progression. Conclusion: Participants receiving BB-101 represented excellent safety profile associated with DFU, paving the way for a new era in DFU care. This study lays the groundwork for further large scale randomized clinical studies. Disclosure J. Ding: Employee; Blue Blood Biotech Corp., Sanar Biotech Corp. P. Fan: None. C. Lin: Employee; Blue Blood Biotech Corp. Consultant; Sanar Biotech Corp. G. Young: None. L. Lo: None. S. Chaichuum: None.
Introduction and Objective: Risk of unstable plaques, noted by reduced content of vascular smooth muscle cells (VSMC) and extracellular matrix (ECM), with elevated inflammatory cells and necrosis, are increased in … Introduction and Objective: Risk of unstable plaques, noted by reduced content of vascular smooth muscle cells (VSMC) and extracellular matrix (ECM), with elevated inflammatory cells and necrosis, are increased in diabetes for unknown reasons. This study investigated the role of insulin in VSMC and the formation of unstable plaques. Methods: Insulin receptor (IR) knockout and VSMC lineage tracing mice (MyH11IRKO/ApoE-/-) were generated. Single cell RNA sequencing (scRNA Seq) was performed with isolated VSMC from control and MyH11IRKO/ApoE-/- mice on normal (ND) or high fat diet (HFD). Changes observed in mice were validated in arteries from subjects with and without Type 2 diabetes (T2D) by immunostaining. Results: Atherosclerotic plaques in MyH11IRKO/ApoE-/- mice were increased and exhibited unstable traits with reductions of VSMC and ECM, but greater numbers of macrophages and necrosis than ApoE-/- mice. ScRNA Seq analysis of aortae identified 21 distinctive clusters of VSMC, which are separated into clusters with enriched expressions of contractile, ribosome and mitochondrial genes to those expressing inflammatory genes. Both inflammatory VSMCs clusters and those enriched for ribosomal and mitochondrial genes were increased in HFD fed ApoE-/- mice vs. those on ND. However, in Myh11IRKO/ApoE-/- mice on HFD, VSMC enriched for ribosomal and mitochondrial genes were significantly reduced, but VSMC expressing elevated inflammatory cytokines and matrix metalloproteinases (MMP’s) were increased vs.HFD fed ApoE-/- mice. These changes of reductions of VSMC with ribosomal proteins and elevations of VSMC with inflammatory cytokines and MMPs were validated in arteries from people with diabetes. Conclusion: scRNA seq analysis showed that insulin actions are critical to prevent the differentiation of VSMC into clusters expressing inflammatory cytokines and MMPs, which are critical for the pathogenesis of unstable arterial plaques associated with insulin resistance and T2D. Disclosure Q. Li: None. J. Fu: None. K. Park: None. M. Yu: None. G.L. King: None.
Introduction and Objective: Patients with diabetes (DM) are at high risk for restenosis after arterial stenting. Information relating the risk of superficial femoral artery (SFA) angioplasty and stent implantation to … Introduction and Objective: Patients with diabetes (DM) are at high risk for restenosis after arterial stenting. Information relating the risk of superficial femoral artery (SFA) angioplasty and stent implantation to prediabetes is limited. Methods: We retrospectively analyzed data of 305 patients (mean age 61.5±3.8 yrs, 65.4% of men) who undertook SFA angioplasty and stent implantation at between Jan 2017 and Dec 2021. Baseline measures included blood pressure (BP), body mass index (BMI), fasting plasma glucose, lipid profile, HbA1c, C-reactive protein (C-RP), and 2-hour capillary glucose. All patients had follow-up Lower extremity computed tomography angiography (LE-CTA) 3.2 years after stent implantation. SFA in-stent restenosis was defined as ≧ 50% stenosis in stent or within 5 mm adjacent to stent. The rate of restenosis was compared among patients with normal glucose tolerance (NGT, n=58), impaired glucose regulation (IGR, n=79), and DM (n=129) according to their baseline glucose levels or prior history of DM. Results: Patients with DM had highest levels of BMI, BP, triglycerides (TG), and C-RP, followed by those with IGR and NGT (p&amp;lt;0.05). At year 3, the rate of restenosis, evaluated by LE-CTA, were 9.8%, 14.5%, and 23.8% in patients with NGT, IGT, and DM, respectively (p&amp;lt;0.05). Among DM subgroup, compared with patients with A1c&amp;lt;8%, those with A1c&amp;gt;8% had increased rate of restenosis (18.6% vs. 25.4%, p&amp;lt;0.05). In the logistic regression model, the odd ratio (OR) of having restenosis was 1.61 (95%CI: 1.13-2.58) for DM and 1.33 (95% CI: 1.09-1.94) for IGR, after adjusting for age, smoking, use of statin, use of anticoagulant drug, BMI, BP, LDL-C, TG, HbA1c and C-RP. Conclusion: SFA in-stent restenosis is more frequent in patients with DM. Prediabetes is associated with increased risk of restenosis after SFA angioplasty and stent implantation during a 3-year follow-up period. The data indicates that intervention of hyperglycemia should be addressed in the management of Lower extremity arterial disease. Disclosure G. Guo: None. L. Zhang: None. L. Li: None. J. Wang: None. Y. Liu: None.
Abstract Thoracofemoral bypass is primarily utilized as a secondary intervention for juxtarenal aortoiliac occlusive disease, with limited instances of its application as an initial treatment, leading to uncertain long-term outcomes. … Abstract Thoracofemoral bypass is primarily utilized as a secondary intervention for juxtarenal aortoiliac occlusive disease, with limited instances of its application as an initial treatment, leading to uncertain long-term outcomes. This analysis aims to scrutinize the 10-year experience and early outcomes of 90 patients who underwent thoracofemoral bypass as a primary procedure. A retrospective analysis was conducted on patients undergoing thoracofemoral bypass for severe aortoiliac occlusive disease between August 2012 and August 2022. The primary indication was complete abdominal aorta obstruction at the renal artery level with an unsuitable site for aorta clamping. The BARD IMPRA expanded polytetrafluoroethylene vascular graft was employed for thoracobifemoral bypass surgery. Among the 90 patients, 83 (92.22%) were male, and 7 (7.78%) were female, with ages ranging from 51 to 77 years. Intraoperative and postoperative data were analyzed, and the mean follow-up duration was 30 days. The 30-day mortality rate was 3.33% (n = 3). Major morbidities included graft occlusion in one patient, managed by embolectomy, and ascites in another patient, addressed conservatively. This study demonstrates that thoracic aorta to femoral artery bypass, as a simple extra-anatomic bypass technique, can yield favorable outcomes when chosen as the initial treatment for patients with juxtarenal total aortoiliac occlusive disease. Thoracofemoral bypass exhibits a safe, acceptable outcome with reliable patency.
Objective: To evaluate the clinical outcomes after endovascular treatment of native femoropopliteal lesions with a drug-coated balloon (DCB) and drug-eluting stent (DES) as a primary option in patients with symptomatic … Objective: To evaluate the clinical outcomes after endovascular treatment of native femoropopliteal lesions with a drug-coated balloon (DCB) and drug-eluting stent (DES) as a primary option in patients with symptomatic peripheral artery disease. Materials and Methods: A comprehensive literature search was performed through PubMed and Embase databases. Studies written in the English language and reporting a direct comparison of the outcomes between primary angioplasty with DCB and primary stenting with DES were included. The endpoints were considered the primary patency (PP), clinical-driven target lesion revascularization (cdTLR), major adverse limb events (free-MALE), and freedom from all-cause mortality. Results: Eleven studies were considered eligible for the metanalysis (3 randomized clinical trials and 8 cohort studies). Overall, 3231 femoropopliteal lesions in 3137 patients were included, with DCB and DES performed in 1951 and 1280 lesions, respectively. No differences were found in demographics, clinical limb presentation, lesions length [173.9±80.2 mm DES vs 195.1±103.3 mm DCB; odds ratio (OR) −2.44; 95% confidence interval (CI) −11.26 to 6.38; p=0.59] and total occlusions (OR 1.41; 95% CI 0.87–2.27; p=0.16). In the DCB group, there was a significant rate of adjunctive procedures such as atherectomy and bailout stenting OR 0.13 (95% CI 0.09–0.18; p&lt;0.001). No differences among PP, cdTLR, free-MALE and freedom from all-cause mortality at 1 year for DCB and DES: OR 1.11 (95% CI 0.74–1.66, p=0.61); OR 1.01 (95% CI 0.72–1.41, p=0.97); OR 1.08 (95% CI 0.69–1.69, p=0.74) and OR 1.85 (95% CI 0.82–4.17, p=0.14) respectively. No differences were found at 2 years: OR 0.89 (95% CI 0.64–1.23, p=0.47); OR 0.79 (95% CI 0.49–1.27, p=0.32); OR 0.74 (95% CI 0.49–1.10, p=0.14); OR 1.21 (95% CI 0.75–1.96, p=0.44) respectively. Conclusions: Both approaches proved to be effective and safe for treating complex femoropopliteal lesions, with comparable clinical outcomes between the 2 groups. In the DCB arm, adjunctive procedures such as atherectomy and bailout stenting were required to optimize the results. Clinical Impact The introduction of drug-coated technologies, such as drug-coated balloons (DCBs) and drug-eluting stents (DESs), has significantly improved clinical outcomes for native femoropopliteal lesions. However, despite ongoing advancements in drug-coated device technology, the optimal treatment approach remains unclear due to limited comparative data in the literature. This meta-analysis aims to bridge this gap by reviewing current evidence, highlighting the latest developments, and providing valuable insights that may aid clinical decision-making in the management of native femoropopliteal lesions.
Background. The development of local treatment of long-term chronic trophic ulcers in severe obliterating atherosclerosis is a relevant problem of modern surgery. Purpose. To study the effectiveness of nafion-based composite … Background. The development of local treatment of long-term chronic trophic ulcers in severe obliterating atherosclerosis is a relevant problem of modern surgery. Purpose. To study the effectiveness of nafion-based composite bandages in the treatment of patients with critical lower limb ischemia and long- term non-healing trophic ulcers. Materials and methods. The controlled, non-randomized study involved 30 people with a trophic defect of the lower leg or foot who underwent arterial reconstructions at the Department of Vascular Surgery of the Republican Clinical Hospital of the Ministry of Health of the Kabardino- Balkarian Republic. The first group (n=13) consisted of patients who got bandages with nafion–based composite material once every 2 days in the postoperative period, the second group (n=17) consisted of patients who were bandaged with Levomekol ointment or iodopyron. The duration of the inpatient and outpatient stage of bandaging was 30 days. The study assessed the healing rate of trophic ulcers, as well as the microbial landscape on its surface. The SPSS Statistics 17.0 software was used for statistical data processing when comparing study groups. Results. In the first group of the study, trophic healing by day 30 was observed in 25.4% of cases, while in the second group of the study — in 17.2%. (p &lt; 0.05). The rate of healing of trophic ulcers in the first 6 days of the study was comparable, but subsequently there was a significant increase in the rate of regeneration in the experimental group (p &lt; 0.05). At the same time, from day 9 in the first group of the study, there was a significant growth of mature granulation tissues, accompanied by a decrease in fibrinous overlays and necrosis. On the 10th day, there was a decrease in pathogenic flora in the main group. In the control group, the level and spectrum of contamination remained the same, only 11.4% of the subjects showed a decrease in microbial associations of E. coli to 102 CFU/tamp. It should be noted that this trend persisted in the study groups up to 21 days. Conclusion. The use of composite bandages with nafion in the treatment of trophic ulcers after arterial reconstructions performed for critical lower limb ischemia accelerates the healing process.
Introducción: La restenosis continúa siendo el gran desafío de la terapia endovascular, por esa razón, se han desarrollado balones liberadores de fármaco (BLF) con la finalidad de reducir la restenosis. … Introducción: La restenosis continúa siendo el gran desafío de la terapia endovascular, por esa razón, se han desarrollado balones liberadores de fármaco (BLF) con la finalidad de reducir la restenosis. El objetivo de este trabajo es analizar los resultados de esta terapia. Material y métodos: Se realizó un análisis retrospectivo de 40 extremidades de pacientes claudicantes con lesiones femoropoplíteas tratados con BLF. Resultados: Se obtuvo el éxito técnico en las 40 (100%) extremidades tratadas con una media de seguimiento de 11,1 mes sin evidencia de complicaciones graves relacionadas con el tratamiento con un 92,5% de las extremidades asintomáticas durante el seguimiento. En tres extremidades se realizó una nueva angioplastia por recidiva sintomática. Conclusiones: El BLF ha probado ser una herramienta útil, segura y eficaz para el tratamiento de lesiones de novo y restenosis intrastent; no obstante, en las lesiones TASC C-D se requiere la utilización de un mayor número de stents.